Chase Tarnstrom Email & Phone Number

San Diego, California, United States

Washington, District Of Columbia, United States

• Individually responsible for developing sections of multiple NDA, BLA, and 510k submissions
• Wrote technical documents and assisted in SOP development
• Assisted in the development of regional regulatory strategy and updated strategy based upon regulatory changes
• Investigated regulatory history/background of class and disease/therapeutic/diagnostic context in order to assess regulatory implications for approval
• Possesses working knowledge of FDA 21 CFR, ISO, and GCP… Show more
• Possesses working knowledge of FDA 21 CFR, ISO, and GCP standards

Washington, District Of Columbia, United States

• Supported FDA division-level program management by creating status reports on 10 workstreams involving complex regulatory and scientific issues such as bioanalytical testing, pharmacological modeling, and genomics
• Tracked the status of 60 research projects and 3 clinical trials within the Division of Applied Regulatory Science (DARS) to ensure deadlines are met
• Supported laboratory information management system (LIMS) IT implementation across 5 DARS laboratories by presenting system… Show more
• Supported laboratory information management system (LIMS) IT implementation across 5 DARS laboratories by presenting system requirements to the Astrix Technology Group
• Drove delivery of services for Booz Allen’s DARS project management support contract enabling it to expand from 2 to 8 billable personnel
• Responsible for training 5 DARS project managers on best practices Show less

Bethesda, Maryland

• Reported to Booz Allen’s health team leadership on the current implementation status of projects related to digital health and patient-focused drug development
• Provided project management support for 4 Center of Excellence in Regulatory Science and Innovation (CERSI) collaborations between DARS and universities such as Harvard, Johns Hopkins, and UCSF-Stanford
• Led the steering committee for Center for Drug Evaluation and Research (CDER) Lab Day, an FDA-wide event with 500+ attendees… Show more
• Led the steering committee for Center for Drug Evaluation and Research (CDER) Lab Day, an FDA-wide event with 500+ attendees including keynote speakers: FDA Commissioner Stephen Hahn and CDER Director Janet Woodcock
• Received the Collective Ingenuity Gold Award for organizing the 2020 CDER Lab Day Show less

Rockville, Maryland

• Organized and coordinated 300+ internal meetings for the CEO and his leadership team and several conferences with high profile Fortune 500 clients
• Received the Passionate Service Bronze Award for organizing the 2018 Civil Technology Strategy Summit